Clinical trial Recruiting at 1 site Observational Ages 5 to 17

Online screening for mental health in children with heart defects

Official title: Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects in Denmark

Run by Copenhagen University Hospital, Rigshospitalet · NCT05709470 · Data updated 2026-11-12

This study is testing an online screening tool to see if it can help identify mental health issues in children with heart defects and provide families with useful information and support.

More Mental Health Issue trials

Quick facts

Study typeObservational
Ages5 Years to 17 Years
SexAll
Enrollment4800 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedMarch 17, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedSeptember 26, 2025
Trial IDNCT05709470 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Danish children and adolescents aged 5-18 years who have been diagnosed with a congenital heart defect.

Probably not a fit

Patients younger than 5 years or older than 18 years, or those lacking sufficient Danish language skills, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Mind the Heart initiative aims to assess the feasibility of an online screening model for mental disorders in Danish children and adolescents diagnosed with congenital heart disease. The study will involve parents completing online questionnaires regarding their child's mental health and psychological support received. Children aged 11 and older will also participate in standardized assessments to evaluate the likelihood of psychiatric diagnoses. The results will be reviewed by trained clinicians, and families will receive a summary report within three months. Additionally, a website will be developed to provide evidence-based information on mental health for families and healthcare professionals.

Why it matters

Potential benefit: If successful, this study could lead to improved identification and treatment of mental health issues in children with congenital heart defects.

How similar studies have gone: Other studies have shown success in using online screening tools for mental health assessments in pediatric populations, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Born with a Congenital Heart Defect
* Age 5-17y
* (Living in Denmark)

Exclusion Criteria:

* Younger than 5years of age
* Older than 17years of age
* Lacking sufficient Danish language skills to answer the questionnaire

Where it's running

  • Department of cardiothoracic surgery, Rigshospitalet
    Copenhagen, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.